Catheter Distal Tip Formation Using Shrink Tube Bonding
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Solution Overview
Problem
The existing methods for forming distal tips for catheters are labor-intensive, prone to human error, and lack consistency due to the manual process of necking and heating, making it difficult to achieve reproducible results across different operators.
Innovation Solution
A method involving a mandrel and holding hypotube with polyether block amides of varying Shore D hardness, where a shrink tube is used to bond the materials, with controlled heating to form a tapering distal tip, reducing human error and improving consistency through automated processes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If manual necking and heating is used to form distal tips, then flexibility in shaping is maintained, but consistency and reproducibility between operators deteriorate
Solution Approach 1:
The patent replaces manual mechanical necking operations with an automated die-based heating and forming system. The die apparatus applies controlled heating and mechanical constraints to the catheter tip material, eliminating operator variability while maintaining the ability to create tapered shapes. This substitution of manual mechanical operations with an automated thermal-mechanical system directly resolves the contradiction between operational flexibility and manufacturing consistency.
Solution Approach 2:
The patent controls and standardizes critical process parameters including heating temperature, heating time, and die geometry to achieve consistent distal tip formation. By establishing specific parameter ranges (temperature, time, pressure) and maintaining them through automated control, the system eliminates the variability inherent in manual operations while preserving the desired shape outcomes.
2Adaptability or versatility
If manual heating with torch is used, then adaptability to different materials is maintained, but heat transfer consistency deteriorates
Solution Approach 1:
The patent replaces manual torch heating with a controlled die-based heating system that provides uniform, consistent thermal input. The die apparatus ensures uniform heat distribution through controlled heating elements, eliminating the variability in heat transfer that occurs with manual torch operations while maintaining versatility across different material types through adjustable heating parameters.
3Ease of operation
If manual necking process is used, then ease of material handling is maintained, but process time and skill requirement increase
Solution Approach 1:
The patent replaces manual necking operations with an automated die-based forming process that reduces both skill requirements and production time. The die apparatus performs the necking and shaping functions automatically through controlled heating and mechanical constraints, eliminating the need for highly skilled operators while reducing the overall process time compared to manual techniques.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The method simplifies the process, reduces human error, and enhances reproducibility by automating the heating and bonding steps, resulting in a consistent and cost-effective production of catheter distal tips with improved material properties.
Implementation Method 1
A shrink tube of heat-shrink material is then placed around at least a junction of the first and second materials. The shrink tube is heated
Implementation Method 2
The shrink tube, first material, and second material are heated to a temperature of about 121°C to 260°C (250°F to 500°F)
Data Source
Figure 1
Figure 2A~2B
Figure 3~4
AI summary
The present disclosure provides various embodiments of methods of forming a tapering distal tip for a catheter. An exemplary method includes providing a mandrel and a holding hypotube, placing a tip first material with a first outer diameter over the mandrel and the hypotube, placing a tip second material with a second outer diameter over the mandrel and under the first material, placing a shrink tube of heat-shrink material around at least a junction of the first material and second material, heating the shrink tube, cooling the first material and second material, and removing the shrink tube and the hypotube. The first outer diameter is greater than the second outer diameter.